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Rathore: What Biosimilar Developers Can Learn From Application Failures
We sat down with Anurag Rathore, PhD, lead author of the study and coordinator of the Center of Excellence for Biopharmaceutical Technology in Delhi, India, to discuss the findings from this study and how biosimilar corporations can learn from them.
Welcome to Not So Different, a podcast from The Center for Biosimilars®. I’m your host, Assistant Editor Skylar Jeremias.
Biologic drug development requires complex processes to obtain desired results, and biosimilar manufacturing is no exception. However, biosimilar developers often run into complications when seeking approval from regulatory authorities. A recent study of failed applications for biosimilar approval revealed multiple reasons why biosimilar applications in the United States and Europe have been such a challenge.
We sat down with Anurag Rathore, PhD, lead author of the study and coordinator of the Center of Excellence for Biopharmaceutical Technology in Delhi, India, to discuss the findings from this study and how biosimilar corporations can learn from them.
To learn more about the study, click here.
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Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
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Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
